FDA Drug recall D-0036-2026
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber… by Aspiro Pharma, citing presence of Particulate Matter: Particulate matter identified as glass.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0036-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-01 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aspiro Pharma |
| Distribution | US |
Product
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Reason
Presence of Particulate Matter: Particulate matter identified as glass
Identifiers
| ndc | 31722-305-25 |
|---|---|
| ndc | 31722-305-10 |
| ndc | 31722-306-25 |
| ndc | 31722-307-25 |
| ndc | 31722-307-02 |
| code_info | Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0036-2026%22
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